Glabellar Frown Lines Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
| Verified date | May 2021 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines
| Status | Completed |
| Enrollment | 301 |
| Est. completion date | April 16, 2020 |
| Est. primary completion date | September 27, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Moderate to severe glabellar lines at maximum frown - Understands the study requirements and signs an informed consent form Exclusion Criteria: - Botulinum toxin treatment in the face within 6 months prior to study treatment |
| Country | Name | City | State |
|---|---|---|---|
| United States | Galderma Study Site | Atlanta | Georgia |
| United States | Galderma Study Site | Austin | Texas |
| United States | Galderma Study Site | Cincinnati | Ohio |
| United States | Galderma Study Site | Coral Gables | Florida |
| United States | Galderma Study Site | Omaha | Nebraska |
| United States | Galderma Study Site | Redondo Beach | California |
| United States | Galderma Study Site | Saint Louis | Missouri |
| United States | Galderma Study Site | San Diego | California |
| United States | Galderma Study Site | Spring | Texas |
| United States | Galderma Study Site | Washington | District of Columbia |
| United States | Galderma Study Site | Westport | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo | Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) | Month 1 after treatment |
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